Myopia, Progressive Clinical Trial
— CEMEOfficial title:
Clinical Evaluation of MyoCare in Europe (CEME): Study Protocol for a Prospective, Multicenter, Randomized, Double-blinded, and Controlled Clinical Trial.
Verified date | June 2023 |
Source | Universidad Complutense de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A 2-year prospective, multicenter, randomized controlled, and double-blind clinical trial is used to investigate the efficacy of a new design of ophthalmic lenses to slow the progression of myopia. 300 children aged from 6 to 13 years old will be recruited and randomly assigned to a study or control group. The study group will be composed of 150 children wearing MyoCare while the control group will be composed of 150 children wearing Clearview. The inclusion criteria will be myopia with a spherical equivalent between -0.75D and -5.00D, astigmatism < 1.50D, and anisometropia < 1.00D, as well as having a historical evolution of at least -0.50 The primary outcome is to compare the mean annual progression of the spherical equivalent between both groups. The secondary outcomes are axial length, choroidal thickness, phorias, and accommodative status of both groups.
Status | Active, not recruiting |
Enrollment | 300 |
Est. completion date | July 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 13 Years |
Eligibility | Inclusion Criteria: - Age 6-13 years - Caucasian ethnicity - Monocular/binocular decimal visual acuity with correction = 1.00 - Spherical equivalent between -0.75D and -5.00D - Astigmatism < 1.50D - Anisometropia < 1.00D - Evolution of at least -0.50D in one year Exclusion Criteria: - Presence of ocular pathology or a history of ocular and systemic abnormalities - Strabismus or binocular vision problems - History of eye surgery - Having previously used some method to control myopia. - Having contraindications for the application of drugs for cycloplegia/corneal anesthesia |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad Complutense de Madrid | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid | Carl Zeiss Vision International GmbH, Cooperativa de Ensino Superior, Politécnico e Universitário, CPO Clinica Privada de Oftalmologia, S.A., ICQO Instituto Quirúrgico de Oftalmología, Instituto de Cirugia Ocular, Miranza Virgen de Lujan, Novovision |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective refraction | Objective refraction will be taken after cycloplegia as the mean of 3 measurements with the i.profiler (Carl Zeiss Meditec AG, Jena, Germany) autorefractometer. The mean annual progression of the objective refraction will be compared between myopic children treated with ZEISS MyoCare lenses and those who wear a conventional single-vision lens. | 2 years | |
Secondary | Axial length | 1. To compare the mean annual progression of axial length between myopic children treated with ZEISS MyoCare lenses and those who wear a conventional single-vision lens. | 2 years |
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